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10-mg dose of XARELTO® now approved for the reduction in the risk of recurrence of DVT/PE in patients at continued risk of DVT/PE*

*After 6 months initial treatment.

EINSTEIN CHOICE: Trial1

  • Comparison of the efficacy and safety of once-daily rivaraoxaban 20 mg and 10 mg with aspirin (100 mg) in VTE patients who completed 6 to 12 months of treatment and were in equipoise regarding the need for extended anticoagulation
  • Randomized, double-blind, active-comparator, event-driven, superiority study
  • Primary Efficacy Outcome: A composite of symptomatic, recurrent fatal or nonfatal VTE and unexplained death for which PE could not be ruled out
  • Principal Safety Outcome: Major bleeding (defined according to the ISTH criteria)
  • Because the benefit-risk assessment favored the 10-mg dose versus aspirin compared to the 20-mg dose versus aspirin, the 10-mg dose is approved for the reduction in the risk of recurrent DVT/PE

Equipoise = a state of uncertainty as to the balance of benefits and harm; ISTH = International Society on Thrombosis and Haemostasis.

XARELTO® is the ONLY NOAC to demonstrate a major bleeding rate as low as aspirin with superior efficacy*1

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*Following 6 to 12 months of initial treatment.

RRR calculated using 1 minus the HR.

View the study

Dosing to reduce the risk of recurrent DVT/PE

MultiDosing_Master-graph

Tablet shown not actual size.

Dosing & administration for DVT/PE initial treatment

The ONLY anticoagulant with a
30-day starter pack for patients with DVT/PE

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Dosing & administration for DVT/PE initial treatment

treatment
  • XARELTO® (15 mg or 20 mg) can be administered orally (as a whole or crushed tablet) or via nasogastric (NG) tube (as a crushed-tablet suspension) followed by food or enteral feeding
  • See how to switch patients to and from XARELTO®
  • View bleed management information for XARELTO®

Tablet shown not actual size.

Renal dosing considerations

  • Treatment of DVT and PE and reduction of risk of recurrence:

    Avoid using XARELTO® in patients with CrCl <30 mL/min


CrCl = creatinine clearance; DVT = deep vein thrombosis; HR = hazard ratio; NG = nasogastric; NOAC = non-vitamin K antagonist oral anticoagulant;
PE = pulmonary embolism; RRR = relative risk reduction; VTE = venous thromboembolism.

 

Indications

 

IMPORTANT SAFETY INFORMATION

 

Indication and Important saftey Information

 

  • Reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). There are limited data on the relative effectiveness of XARELTO® (rivaroxaban) and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.
  • Treatment of deep vein thrombosis (DVT).
  • Treatment of pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery.

References:

  1. Eriksson BI, Borris LC, Friedman RJ, et al; for the RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  2. Data on file. Janssen Pharmaceuticals, Inc.
  3. Kakkar AK, Brenner B, Dahl OE, et al; for the RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  4. Lassen MR, Ageno W, Borris LC, et al; for the RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.

References:

  1. Weitz JI, Lensing AWA, et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Eng J Med. 2017;376:1211-1222.